Statistics show lung cancer is the leading cause of cancer death in African-Americans, with 21,550 new cases expected to be diagnosed and 16,700 deaths expected this year. Equally devastating, lung cancer is the leading cause of cancer death in Hispanic men and the second leading cause of cancer death in Hispanic women. Researchers at Eli Lilly and Company are actively investigating the efficacy and safety of lung cancer treatments ALIMTA® (pemetrexed for injection) and GEMZAR® (gemcitabine HCl for injection) in treating non-small cell lung cancer (NSCLC) in African-Americans, Hispanics and other diverse populations.
Two retrospective Lilly studies were unveiled today at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill. They offered cursory insight into how a diverse group of patients respond to treatment with Lilly chemotherapeutic options. One study analyzed data of chemonaïve African-American patients with stage IIIB/IV NSCLC treated with GEMZAR in combination with carboplatin or paclitaxel (Taxol®) versus patients taking carboplatin in combination with paclitaxel. The second study provided data from six previous trials for non-Caucasian patients with advanced or metastatic NSCLC treated with ALIMTA.
“African-Americans are often underrepresented in clinical trials and, therefore, little is known about the possible impact of race on the utility of many medications,” said Coleman Obasaju, M.D., Ph.D., United States oncology medical director of Lilly and the principal investigator of these two studies. “Because lung cancer is a particularly devastating disease, and a growing concern in the African-American population, it was a logical starting point for our analysis.”
The GEMZAR study released at ASCO analyzed overall survival data from a previous randomized Phase III trial in the treatment of NSCLC, viewing data outcomes and toxicity data of 128 African-Americans compared with 906 Caucasians. The trial was designed to compare the efficacy of GEMZAR plus carboplatin with GEMZAR plus paclitaxel and a reference regimen of carboplatin plus paclitaxel. Data from all three arms were pooled for this analysis. Overall survival, the primary endpoint, on the African-American arm was 8.7 months compared to 8.1 months in the Caucasian arm, which was not significantly different. African-Americans demonstrated slightly lower incidences of grade 3/4 toxicities (constitutional, hemorrhagic and metabolic).
The ALIMTA study reviewed a post-hoc analysis of pooled data from six previous trials, including one Phase III in a second-line setting and five Phase II trials in a first-line setting. Patients with Stage IIIB/IV NSCLC were given at least one dose of ALIMTA (single-agent or in combination with other treatments) every 21 days. The trial evaluated results from 411 Caucasian patients compared with 117 non-Caucasian (African-American, Asian and Hispanic) patients. Based on this analysis, race did not have a statistically significant impact on efficacy parameters (response rate, survival and disease control rate). Non-Caucasian patients had lower grade 3/4 toxicities, including neutropenia (a decrease in white blood cells); anemia (a decrease in red blood cells); fatigue; and nausea.
“At the very least, the data unveiled today suggests that we should continue actively studying the impact of our medications on a diverse number of populations,” said Dr. Obasaju.
To that end, Lilly recently began enrollment into what may be the largest and most diverse Phase III study in NSCLC. The study will evaluate ALIMTA in 1,000 patients with NSCLC. Enrollment will include 200 African-Americans, 200 Asians, 200 Hispanics and 400 Caucasians. For more information on this trial visit
www.lillytrials.com or
www.clinicaltrials.gov.
“Scientific reasoning tells us that because of genetic differences, patients with similar tumors may respond differently to specific treatment regimens,” said Richard Gaynor, M.D., vice president, cancer research and global oncology platform leader at Lilly. “Ultimately, our goal is to ensure that we offer the optimal outcome to each and every patient.”
Source: CPR Worldwide
Related stories:
Studies suggest key correlation between lung cancer subtype and treatment outcomes
In clinical research, patients with advanced non-small cell lung cancer (NSCLC) that are classified as having a non-squamous histology achieve statistically significant higher survival when treated in the second-line setting with ALIMTA® (pemetrexed for injection) when compared to histologically-similar patients treated with docetaxel. The data were presented at the 14th European Cancer Conference (ECCO) in Barcelona. ALIMTA, manufactured and marketed by Eli Lilly and Company, is currently indicated for the second-line treatment of advanced NSCLC in more than 85 countries.
Counting tumor cells in blood predicts treatment benefit in prostate cancer
Counting the number of tumor cells circulating in the bloodstream of patients with castration-resistant prostate cancer can accurately predict how well they are responding to treatment, new results show.
Treatment delays result in poor outcomes for men with breast cancer
Men who develop breast cancer are often not treated until the disease has spread to the point that treatment becomes difficult, new results show.
Researchers clarify function of glucose transport molecule
Researchers at the David Geffen School of Medicine at UCLA have solved the structure of a class of proteins known as sodium glucose co-transporters (SGLTs), which pump glucose into cells. These transport proteins are used in the treatment of chronic diarrhea via oral rehydration therapy, saving the lives of millions of children each year. The solution of the SGLT structure will accelerate development of new drugs designed to treat patients with diabetes and cancer.
Blood vessel inhibitor shows promise against metastatic thyroid cancer
Thyroid cancer that has spread to distant sites has a poor prognosis, but an experimental drug that inhibits tumor blood vessel formation can slow disease progression in some patients, a research team led by investigators from The University of Texas M. D. Anderson Cancer Center reports in the July 3rd edition of
The New England Journal of Medicine.
Circulating tumor cells can reveal genetic signature of dangerous lung cancers
Massachusetts General Hospital (MGH) investigators have shown that an MGH-developed, microchip-based device that detects and analyzes tumor cells in the bloodstream can be used to determine the genetic signature of lung tumors, allowing identification of those appropriate for targeted treatment and monitoring genetic changes that occur during therapy. A pilot study of the device called the CTC-chip will appear in the July 24
New England Journal of Medicine and is receiving early online release.
FSU researcher using computers to hone cancer-fighting strategies
A Florida State University faculty member who uses computational techniques to evaluate a new class of cancer-killing drugs is attracting worldwide attention from other researchers.
Analysis of cancer incidence, mortality and survival combined reveals encouraging European trends
The first research to look at recent trends in European cancer incidence, mortality and survival together has shown that cancer prevention and management in Europe is moving in the right direction. However, the research reveals that variations between countries in policies for mass screening, access to health care and treatment are reflected in the different cancer rates.